KHEIRON - Large, open derotation offset connector - S.M.A.I.O

Duns Number:260585710

Device Description: Large, open derotation offset connector

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

24PW56625

Brand Name

KHEIRON

Version/Model Number

24PW56625

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

ea935f9f-acf5-4dc0-b6ed-b3fc4c588c2d

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S.M.A.I.O" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 115
2 A medical device with a moderate to high risk that requires special controls. 244